Monitoring low-risk skin cancer in elderly patients without immediate treatment
Investigating Active Surveillance for Management of Low-Risk Basal Cell Carcinoma in the Elderly
This study is testing if watching and waiting instead of treating low-risk skin cancer right away is a comfortable and satisfying option for older patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06539468 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and comfort of active surveillance (AS) as an alternative to standard treatment for elderly patients with low-risk basal cell carcinoma (LR-BCC). The study aims to compare patient satisfaction between those receiving AS and those undergoing standard of care (SOC) treatments over a one-year follow-up period. It also seeks to gather pilot data on the acceptability of AS and its feasibility for future larger trials. Participants will be monitored for clinical outcomes and healthcare utilization related to their treatment options.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older with a recent diagnosis of low-risk basal cell carcinoma.
Not a fit: Patients with immunocompromised conditions or those requiring immediate treatment for their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive management option for elderly patients with low-risk skin cancer, reducing treatment-related complications.
How similar studies have performed: While active surveillance has been shown to be a safe management strategy in other contexts, this specific approach for low-risk basal cell carcinoma in elderly patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject of any gender aged ≥ 65 years at the time of enrollment * Patient at University of Michigan Department of Dermatology (UMichDD) * Willing and able to provide informed consent * Willing and able to comply with the protocol requirements * Histopathologic diagnosis of one or more LR-BCC(s) within 2 months of enrollment. LR-BCC is defined here as biopsy proven primary (not recurrent) BCC of any morphologic subtype; \< 2cm in size; with or without marginal involvement on histopathology; and located on the trunk or extremities excluding pretibial surface, hands, feet, nail units, and ankles (corresponding to area L in the Mohs Appropriate Use Criteria, representing the lowest risk areas) Exclusion Criteria: * Individuals who are immunocompromised per judgement of investigator (examples include but are not limited to patients on immunosuppressive medications such as prednisone \> 10 mg daily, uncontrolled HIV, and organ transplant recipients on immunosuppressive therapy) * Individuals who expect to relocate and will be unable to return to UMichDD for clinical follow-up visit(s) * Individuals with a genetic syndrome predisposing to development of basal cell carcinoma
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Allison Billi — University of Michigan Rogel Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.